Q&A on CGMPs

Q&A on CGMPs

As part of the Current Good Manufacturing Practices (CGMP) initiative announced in August of 2002, and to help FDA be more transparent with CGMP policy, we have developed this question and answer resource on current good manufacturing practices. We intend to use this format to provide timely answers to questions about the meaning and application of CGMPs for human, animal, and biological drugs, and to share these widely. These questions and answers clarify statements of existing requirements or policy that are minor in nature, and as such, are considered Level 2 guidance. You may submit comments on this guidance at any time. Submit comments to Docket No. FDA-2017-D-6821 (see the instructions for submitting comments in the docket). This resource is being cosponsored by CDER, CVM, CBER, and ORA. The Q&As generally clarify the existing CGMP regulations for finished pharmaceuticals: 21 CFR part 211